Menveo (meningococcal-groups A, C, W-135 and Y oligosaccharide CRM197 conjugate vaccine) / GSK - LARVOL DELTA

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1 | N=551 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever (clinicaltrials.gov) - P1/2 | N=155 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Infectious Disease

Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old (clinicaltrials.gov) - P2/3 | N=1123 | Recruiting | Sponsor: EyeGene Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Meningococcal Infections

Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old (clinicaltrials.gov) - P2/3 | N=1123 | Not yet recruiting | Sponsor: EyeGene Inc.

New P2/3 trial • Infectious Disease • Meningococcal Infections

VAC087: A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M (clinicaltrials.gov) - P2 | N=360 | Not yet recruiting | Sponsor: University of Oxford

New P2 trial • Infectious Disease • Malaria

Investigating a Vaccine Against COVID-19 (clinicaltrials.gov) - P2/3 | N=10811 | Completed | Sponsor: University of Oxford | Active, not recruiting ➔ Completed | Trial completion date: Mar 2024 ➔ Feb 2025 | Trial primary completion date: Mar 2024 ➔ Feb 2025

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1215 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Meningococcal Infections

Penmenvy - a second pentavalent meningococcal vaccine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Meningococcal Infections

Study of immunogenicity and safety of MenQuadfi® as a booster vaccine in toddlers 12 to 23 months, regardless of the quadrivalent meningococcal conjugate vaccine used for priming in infancy. (clinicaltrialsregister.eu) - P4 | N=180 | Sponsor: Sanofi Pasteur

New P4 trial • Dermatology • Infectious Disease • Meningococcal Infections

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1 | N=552 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | Phase classification: P1/2 ➔ P1

Enrollment closed • Phase classification

HOPE II: Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV. (clinicaltrials.gov) - P4 | N=750 | Recruiting | Sponsor: Massachusetts General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease • Oncology

A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults (clinicaltrials.gov) - P1/2 | N=1429 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Meningococcal Infections

Analytical Challenges in Novel Pentavalent Meningococcal Conjugate Vaccine (A, C, Y, W, X). (PubMed, Vaccines (Basel)) - "Well-known meningococcal vaccines such as MenAfriVac, Nimenrix, Menveo, and MenQuadfi are licensed in various parts of the world and have been successful. Additional analytical challenges include the impact of excipients, potential interference from serogroups, selection and establishment of standards, age-dependent behavior of biomolecules indicated by molecular size distributions, and process-driven variations. This article explains the analytical insights gained (polysaccharide content, free saccharide, free proteins, MSD) during the development of the MenFive vaccine and highlights the crucial gaps and challenges in testing."

Journal • Review • CNS Disorders • Infectious Disease • Meningococcal Infections • Tetanus

Interim safety data from a phase 1/2a, randomized, controlled, observer-blind trial to evaluate the safety, reactogenicity and immunogenicity of a trivalent vaccine against invasive nontyphoidal Salmonellosis (iNTS) and Typhoid Fever in healthy . (ASTMH 2024) - "In stage 1, 50 European adults were randomized in a 2:2:1 ratio to receive either iNTS-TCV vaccine and concomitant saline in different arms, or separate iNTS-GMMA and TCV vaccines in different arms, or placebo and saline in different arms intramuscularly, on Days 1, 57 and 169...Menveo, Boostrix and Typhim Vi are administered as controls for the 1 st , 2 nd and 3 rd doses respectively...In conclusion, based on available data, the anticipated benefit/risk profile of the iNTS-TCV vaccine continues to be positive, with no safety concerns precluding further clinical development. First immunogenicity results are expected later in 2024 and would be presented at the congress."

Clinical • P1/2 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Pain

Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age (clinicaltrials.gov) - P3 | N=943 | Completed | Sponsor: GlaxoSmithKline | Trial completion date: Jul 2024 ➔ Nov 2023

Trial completion date • Infectious Disease • Meningococcal Infections

Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy (clinicaltrials.gov) - P4 | N=71 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Completed | N=180 ➔ 71

Enrollment change • Trial completion • Infectious Disease • Meningococcal Infections

An Open Label Study of IgG Fc Glycan Composition in Human Immunity (clinicaltrials.gov) - P1 | N=129 | Terminated | Sponsor: Rockefeller University | Phase classification: P=N/A ➔ P1 | Active, not recruiting ➔ Terminated; Inadequate enrollment

Phase classification • Trial termination

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1220 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Meningococcal Infections

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1220 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Initiation date: Jan 2023 ➔ Oct 2023

Trial initiation date • Infectious Disease • Meningococcal Infections

HOPE II: Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV. (clinicaltrials.gov) - P4 | N=750 | Not yet recruiting | Sponsor: Massachusetts General Hospital

New P4 trial • Human Immunodeficiency Virus • Infectious Disease • Oncology

A study on the safety, reactogenicity, and immune response to the GVGH iNTS-GMMA vaccine against invasive nontyphoidal Salmonella in adults, children, and infants. (clinicaltrialsregister.eu) - P1/2 | N=516 | Sponsor: GLAXOSMITHKLINE BIOLOGICALS SA

New P1/2 trial • Dermatology • Infectious Disease

Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy (clinicaltrials.gov) - P4 | N=180 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial primary completion date: Apr 2024 ➔ Sep 2024

Trial primary completion date • Infectious Disease • Meningococcal Infections

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1220 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Initiation date: Oct 2023 ➔ Jan 2023

Trial initiation date • Infectious Disease • Meningococcal Infections

Use of the Pfizer Pentavalent Meningococcal Vaccine Among Persons Aged ≥10 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023. (PubMed, MMWR Morb Mortal Wkly Rep) - "Two quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccines (MenACWY) (MenACWY-CRM [Menveo, GSK] and MenACWY-TT [MenQuadfi, Sanofi Pasteur]) and two serogroup B meningococcal vaccines (MenB) (MenB-4C [Bexsero, GSK] and MenB-FHbp [Trumenba, Pfizer Inc.]), are licensed and available in the United States and have been recommended by CDC's Advisory Committee on Immunization Practices (ACIP). Different manufacturers' serogroup B-containing vaccines are not interchangeable; therefore, when MenACWY-TT/MenB-FHbp is used, subsequent doses of MenB should be from the same manufacturer (Pfizer Inc.). This report summarizes evidence considered for these recommendations and provides clinical guidance for the use of MenACWY-TT/MenB-FHbp."

Journal • Immunology • Infectious Disease • Meningococcal Infections • Primary Immunodeficiency

Monophosphoryl Lipid A-based Adjuvant to Promote the Immunogenicity of Multivalent Meningococcal Polysaccharide Conjugate Vaccines. (PubMed, Immunohorizons) - "Many Gram-negative bacterial polysaccharide vaccines, including the tetravalent meningococcal conjugate vaccines (MCV4) and typhoid Vi polysaccharide vaccines, do not incorporate adjuvants...Consistent with this hypothesis, two Food and Drug Administration-approved MCV4 vaccines, MENVEO and MenQuadfi, lack TLR4 ligands...Turbo upregulated the expression of the costimulatory molecules CD40 and CD86 on B cells, and Turbo-driven adjuvanticity is lost in mice deficient in CD40 and CD86. These data suggest that Turbo induces the required costimulatory molecules for its adjuvant activity and that incorporation of Turbo could make bacterial polysaccharide vaccines more immunogenic, minimize booster requirements, and be cost-effective, particularly for those individuals in low- and middle-income and disease-endemic countries."

IO biomarker • Journal • Infectious Disease • Meningococcal Infections • CD40 • CD86 • TLR4